Stent delivery system and method of use

ABSTRACT

Described herein are various methods and apparatuses for delivering stents and other devices into the myocardium of a patient. One preferred stent delivery system provides access to the insertion site in the myocardium by advancing a delivery catheter through a blockage in a coronary artery, or around the blockage through a coronary vein or through a channel or tunnel formed around the blockage. In one embodiment, once the distal end of the delivery catheter is adjacent the myocardium, an angled bend is created in the catheter by actuating expandable steering guides mounted to the catheter which cooperate with the walls of the blood vessel to cause the catheter to turn. Then, a guidewire is advanced through the delivery catheter and into the myocardium. In another embodiment, a tip-deflecting pull wire extends from the distal end of the delivery catheter which may be actuated to turn towards and then inserted into the myocardium. In another embodiment, an exit port facing the insertion site is provided within the catheter or a balloon mounted on the catheter so that a guidewire may be directed through a lumen and out the exit port into the myocardium. Once the guidewire punctures into the myocardium, the guidewire is anchored using barbs, balloons or other actuatable members to secure the guidewire to the myocardium. Subsequently, using a push-pull mechanism, stents and other medical devices can be advanced over the guidewire into the myocardium.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to the deliver, of a stent andother devices into the myocardium of a patient, and more particularly,to a stent delivery system to provide a bypass through the myocardiumfrom the left ventricle into a coronary artery.

[0003] 2. Description of the Related Art

[0004] Coronary arteries as well as other vessels frequently becomeclogged with plaque that at the very least impairs the efficiency of theheart's pumping action and can lead to heart attack and death. Oneconventional treatment for clogged coronary or other arteries is abypass operation wherein one or more venous segments are insertedbetween the aorta and the coronary artery. The inserted venous segmentsor transplants act as a bypass of the clogged portion of the coronaryartery and thus provide for a free or unobstructed flow of blood to theheart.

[0005] Such coronary artery bypass surgery, however, is expensive,time-consuming and traumatic to the patient. Hospital stays subsequentto the surgery and convalescence are prolonged.

[0006] A new coronary artery bypass technique is disclosed in U.S. Pat.No. 5,429,144. That technique utilizes a stent made of a biocompatiblematerial and comprises steps of moving the stent in a collapsedconfiguration through a blood vessel of a patient's vascular system tothe patient's heart, inserting the stent in the patient's myocardium,and upon disposition of the stent in the myocardium, expanding the stentfrom the collapsed configuration to a substantially tubular expandedconfiguration so that a blood flow path is formed at least partiallythrough the myocardium.

[0007] One problem with the coronary artery bypass method providing astent through the myocardium of the heart is how to get the stent intothe myocardium. U.S. Pat. No. 5,429,144 describes a percutaneousapproach wherein the stent is brought to the myocardium through thepatient's vasculature on the distal end of a catheter, and advanced intothe myocardium over a guidewire. One particular challenge is how to makean angled bend in the guidewire to puncture through the wall of thevessel and into the myocardium.

[0008] Another problem with this approach is that catheters deliveringthe guidewvire, stent or other devices to be provided into themyocardium are conventionally guided to the puncture point through theblockage in the coronary artery. However, when the blockage is toolarge, a delivery catheter cannot access the desired insertion site.

[0009] In addition, it is often difficult to advance devices into themyocardium because of the traction and force necessary to push throughthe myocardium. This problem arises not only for delivery of the stent,but also for the delivery of dilation catheters used to expand thecross-section of the passageway through the myocardium, and otherdevices.

[0010] Accordingly, what is needed is a method and apparatus fordelivering guidewires, stents and other devices into the myocardium. Inparticular, what is needed is a delivery system that can deliver thesedevices at an angled bend for transverse insertion into the myocardium.Moreover, what is needed is a deliver, method and apparatus foradvancing a delivery catheter to a puncture site in a coronary vesselwhen the blockage in the vessel is too large to permit passage of acatheter therethrough. What is also needed is a method and apparatus foradvancement of a stent, dilation catheter or other device into andthrough the myocardium.

SUMMARY OF THE INVENTION

[0011] Briefly stated, the present invention addresses the above needsby providing various methods and apparatuses for delivering stents andother devices into the myocardium of a patient. One preferred stentdelivery system provides access to the insertion site in the myocardiumby advancing a delivery catheter through a blockage in a coronaryartery, or around the blockage through a coronary vein or through achannel or tunnel formed around the blockage. In one embodiment, oncethe distal end of the delivery catheter is adjacent the myocardium, anangled bend is created in the catheter by actuating expandable steeringguides mounted to the catheter which cooperate with the walls of theblood vessel to cause the catheter to turn. Then, a guidewire isadvanced through the delivery catheter and into the myocardium. Inanother embodiment, a tip-deflecting pull wire extends from the distalend of the delivery catheter which may be actuated to turn towards andthen inserted into the myocardium. In another embodiment, an exit portfacing the insertion site is provided within the catheter or a balloonmounted on the catheter so that a guidewire may be directed through alumen and out the exit port into the myocardium. Once the guidewirepunctures into the myocardium, the guidewire is anchored using barbs,balloons or other actuatable members to secure the guidewire to themyocardium. Subsequently, using a push-pull mechanism, stents and othermedical devices can be advanced over the guidewire into the myocardium.

[0012] In one aspect of the present invention, a guidewire is deliveredinto the patient such that the proximal end of the guidewire extends outof the patient, while the distal end of the guidewire is positionedadjacent the myocardium. The distal end of the guidewire is insertedinto the myocardium, and the guidewire is then anchored to themyocardium. An introducer catheter carrying a medical device is advancedover the guidewire to deliver the device into the myocardium.

[0013] In another aspect of the present invention, a method fordelivering a stent into the myocardium to bypass a blockage formed in acoronary artery is provided. A channel is created from a positionproximal to the blockage in the coronary artery to a position distal tothe blockage in the coronary artery. A guidewire is advanced through thechannel until a distal end of the guidewire is adjacent the myocardium.The guidewire is inserted into the myocardium, and a stent is advancedover the guidewire into the myocardium.

[0014] In another aspect of the present invention, a method is providedfor creating a bypass through the myocardium of a patient to bypass ablockage formed in a coronary artery. A first tunnel is created throughthe myocardium having a proximal end and a distal end. The proximal endof the tunnel opens into the coronary artery proximal to the blockage.The distal end of the tunnel is positioned within the myocardium. Asecond tunnel is created through the myocardium, the second tunnelhaving a first branch extending from the distal end of the first tunneland opening into the coronary artery at a position distal to theblockage. A second branch of the second tunnel extends from the distalend of the first channel and opens into the left ventricle. A stent isdisposed in the second tunnel to provide a myocardial passagewaytherethrough.

[0015] In another aspect of the present invention, a delivery catheteris provided. This delivery catheter comprises an elongate tubular bodyhaving a proximal end and a distal end and a lumen extendingtherethrough. A first steering member is mounted on the distal end ofthe tubular body, and a second steering member is mounted on the distalend of the tubular body at a position distal to that of the anchoringmember.

[0016] In another aspect of the present invention, a method for turninga distal end of a catheter within a body lumen is provided. The cathetercomprises an elongate tubular body having a proximal end and a distalend. An anchoring member mounted to the distal end is actuated to securethe catheter against the body lumen. A steering member is mounted to thedistal end of the of the guidewire at a position distal to that of theanchoring member. When actuated, the steering member cooperates with thebody lumen to turn the distal end of the catheter.

[0017] In another aspect of the present invention, a method is providedfor delivering a medical device to a delivery site within a patient.This method comprises providing a delivery catheter having a proximalend and a distal end and a lumen extending therethrough into a bodylumen of the patient. The delivery catheter is secured within the bodylumen. The distal end of the catheter is turned by actuating a steeringmember mounted on the distal end of the catheter which pushes offagainst a wall of the body lumen. The medical device is advanced throughthe lumen of the delivery catheter and out the distal end.

[0018] In another aspect of the present invention, a method fordelivering a stent into the myocardium of a patient is provided. Adelivery catheter is advanced into the vasculature of the patient, thedelivery catheter having a proximal end and a distal end and a lumenextending therethrough, until the distal end is adjacent the myocardium.A pull wire extending from the distal end of the delivery catheter isactuated to turn the pull wire toward the myocardium. The pull wire isadvanced from the distal end of the delivery catheter into themyocardium. The stent is delivered over the pull wire into themyocardium.

[0019] In another aspect of the present invention. a method fordelivering a stent into the myocardium of a patient is provided. Adelivery catheter is advanced into the vasculature of the patient, thecatheter having a proximal end and a distal end and a lumen extendingfrom the proximal end to a side port near the distal end, until the sideport faces the myocardium. A guidewire having a proximal end and adistal end is inserted into the lumen. The distal end of the guidewireis advanced through the lumen and out the side port. The guidewirepunctures into the myocardium, and the stent is delivered over theguidewire into the myocardium.

[0020] In another aspect of the present invention, a method fordelivering a stent into the myocardium of a patient is provided. Adelivery catheter is advanced into the vasculature of a patient, thecatheter having a proximal end and a distal end, until the distal end isadjacent the myocardium. An anchoring member mounted on the distal endof the catheter is expanded to secure the delivery catheter within thevasculature. A guidewire having a proximal end and a distal end isinserted through a lumen in the expanded anchoring member, the lumenextending from a proximal end of the anchoring member to a side portfacing the myocardium, so that the distal end of the guidewvire exitsthrough the side port. The guidewire punctures into the myocardium. andthe stent is advanced over the guidewire into the myocardium.

[0021] In another aspect of the present invention, a delivery catheteris provided. The catheter comprises an elongate body having a proximalend and a distal end. An expandable member is mounted on the distal endof the tubular body, the expandable member having a proximal end and adistal end and an exterior surface. A guide lumen extends from theproximal end of the balloon to a side port on the exterior surface ofthe expandable member for directing a medical device therethrough.

[0022] In another aspect of the present invention, a method for treatingan aneurysm is provided. A catheter having a proximal end and a distalend is advanced to the site of the aneurysm. An expandable membermounted on the distal end of the catheter is actuated to substantiallyenclose the aneurysm. An embolic element is inserted through a lumen inthe expandable member into the aneurysm.

[0023] In another aspect of the present invention, a method fordelivering a medical device into a body tissue of a patient is provided.The method comprises inserting a guidewire having a proximal end and adistal end into the myocardium from a coronary blood vessel. Theguidewire is anchored to the body tissue, and the medical device ispushed over the guidewire into the body tissue. The proximal end of theguidewire is correspondingly pulled proximally while the medical deviceis pushed distally in order to assist advancing the medical devicethrough the body tissue.

[0024] In another aspect of the present invention, a delivery system fordirecting medical treatment at least partially into the myocardium isprovided. The delivery system comprises a guidewire having a proximalend and a distal end, means for turning the distal end of the guidewiretoward the myocardium, means for anchoring the guidewire to themyocardium, and a catheter carrying the medical treatment having a lumenextending therethrough for receiving the guidewire and advancing thecatheter into the myocardium.

[0025] In another aspect of the present invention, a method fordelivering a stent into the myocardium of a patient to bypass a blockageformed in a coronary artery is provided. The method comprises advancinga catheter having a proximal end and a distal end and a lumen extendingat least partially therethrough from the proximal end to a distalopening through the coronary artery of the patient until the distalopening is past the blockage. The catheter is turned so that the distalopening faces the myocardium. A wire having a proximal end and a distalend is extended through the distal opening such that the distal endpunctures into the myocardium. The distal end of the wire is anchored tothe myocardium. A dilation catheter is delivered over the wire, thecatheter carrying a dilation balloon on a distal end thereof, until theballoon is within the myocardium. The dilation balloon is inflated tocreate an opening in the myocardium. The dilation balloon is thendeflated and the dilation catheter removed from the wire. A stentintroducer catheter is delivered over the wire, the stent introducercatheter carrying a stent on a distal end thereof, until the stent islocated within the opening in the myocardium. The stent is deployedwithin the opening in the myocardium.

[0026] In another aspect of the present invention, a method fordelivering medical treatment into the myocardium of a patient isprovided. A tubular wire is delivered into the patient, the wire havinga lumen extending therethrough. The wire once delivered has a proximalend extending out of the patient and a distal end positioned adjacentthe myocardium. Means for turning the distal end of the wire towards themyocardium are provided. Then, the distal end of the wire is insertedinto the myocardium. Medical treatment is delivered through the lumen inthe wire into the myocardium.

BRIEF DESCRIPTION OF THE DRAWINGS

[0027]FIG. 1A is a schematic, cross-sectional view of a human heart,showing a stent in the myocardium of the heart for forming a bypassshunt between the left ventricle and a coronary artery.

[0028]FIG. 1B is an enlarged view of the bypass shunt of FIG. 1A.

[0029]FIG. 2 is a schematic, partial cross-sectional view of a humanheart. showing a stent extending partially into the myocardium from theleft ventricle.

[0030]FIG. 3A is a schematic, partial cross-sectional view of a coronaryartery adjacent the left ventricle, showing a delivery catheter beingadvanced through a blockage in the coronary artery.

[0031]FIG. 3B is a schematic, partial cross-sectional view of a coronaryartery adjacent the left ventricle, showing a delivery catheter beingadvanced into the left ventricle.

[0032]FIG. 4A is a schematic side view of a venous access route througha patient's heart.

[0033]FIG. 4B is a schematic, partial cross-sectional view of the venousaccess route of FIG. 4A between a coronary vein and a coronary artery,showing a delivery catheter being advanced through the coronary veininto the coronary artery.

[0034]FIG. 5 is a schematic, partial cross-sectional view of a coronaryartery adjacent the left ventricle, showing a tunnel formed through themyocardium to bypass a blockage in the coronary artery.

[0035]FIG. 6 is a schematic. partial cross-sectional view of a coronaryartery adjacent the left ventricle, showing a delivery catheter beingadvanced through a tunnel formed through the myocardium.

[0036]FIG. 7 is a schematic, partial cross-sectional view of a coronaryartery, adjacent the left ventricle, showing a Y-shaped tunnel formedthrough the myocardium to bypass a blockage in the coronary artery.

[0037]FIG. 8 is a partial cross-sectional view of the Y-shaped tunnel ofFIG. 7, showing a stent provided therein.

[0038]FIG. 9 is a side view of a delivery catheter carrying twouninflated steering balloons in a blocked coronary artery, with theartery shown partially cut away.

[0039]FIG. 10 is a side view of the delivery catheter of FIG. 9, showingthe two balloons partially inflated.

[0040]FIG. 11 is a side view of the delivery catheter of FIG. 9, showingthe two balloons fully inflated and a guidewire extending from thedistal end of the delivery catheter.

[0041]FIG. 12 is a side view of a delivery catheter with a tipdeflecting wire in a blocked coronary artery, with the artery shownpartially cut away.

[0042]FIG. 13A is a side view of a delivery catheter having a side portproximal to an inflatable balloon in a blocked coronary artery, with theartery shown partially cut away.

[0043]FIG. 13B is a cross-sectional view of the delivery catheter ofFIG. 13A, further showing a guidewire extending therethrough.

[0044]FIG. 14A is a side view of a delivery catheter having a side portdistal to an inflatable balloon in a blocked coronary artery, with theartery shown partially cut away.

[0045]FIG. 14B is a cross-sectional view of the delivery catheter ofFIG. 14A, further showing a guidewire extending therethrough.

[0046]FIG. 15A is a side view of a delivery catheter having a side portwithin an inflatable balloon in a blocked coronary artery, with theartery shown partially cut away.

[0047]FIG. 15B is a cross-sectional view of the delivery catheter ofFIG. 15A, further showing a guidewire extending through the balloon.

[0048]FIG. 15C is a side view of an alternative embodiment of a deliverycatheter having a side port within an inflatable balloon in a blockedcoronary artery, with the artery shown partially cut away.

[0049]FIG. 15D is a cross-sectional view of the delivery catheter ofFIG. 15C, further showing a guidewire extending through the balloon.

[0050]FIG. 16 is a side view of a delivery catheter having a side portwithin an inflatable balloon used for treating an aneurysm in a bloodvessel, with the vessel shown partially cut away.

[0051]FIG. 17 is a side view of an anchoring guidewire extending throughthe myocardium, with the myocardium shown partially cut away.

[0052]FIG. 18A is a side view of a guidewire carrying an inflatableballoon on its distal end extending through the myocardium, with themyocardium shown partially cut away.

[0053]FIG. 18B is a side view of the guidewire of FIG. 18A, showing theballoon inflated to anchor the guidewire against the myocardium.

[0054]FIGS. 19A-19C are side views of an alternative embodiment of aguidewire anchored to the inner wall of the myocardium, with themyocardium shown partially cut away.

[0055]FIG. 20 is a side view of a dilation catheter in a coronary arteryadvanced over a guidewire extending into the myocardium, with the arteryand the myocardium shown partially cut away.

[0056]FIG. 21 is a side view of the dilation catheter of FIG. 20advanced into the myocardium.

[0057]FIG. 22 is a side view of a stent introducer catheter in acoronary artery advanced over a guidewire extending into the myocardium,with the artery and myocardium shown partially cut away.

[0058]FIG. 23 is a side view of the stent introducer catheter of FIG. 2advanced into the myocardium.

[0059]FIG. 24 is a side view of a drug delivery wire advanced through acoronary artery into the myocardium, with the artery and the myocardiumshown partially cut away.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0060] The preferred embodiments described hereinbelow depict methodsand apparatuses for delivering a stent into the myocardium to create apassageway between the left ventricle and coronary artery. It should beappreciated, however, that these embodiments may also be applied to thedelivery of stents and other medical devices into other body tissues andvessels, and are particularly applicable for delivering devices at anangled bend relative to the axis of blood flow. In addition, thedelivery methods and apparatuses described herein pertain to theplacement of stents and other devices partially through the myocardium,as well as for drug delivery and similar applications.

[0061] As illustrated in FIGS. 1A and 1B, a coronary artery bypass isaccomplished by disposing a stent 10 in a heart wall or myocardium MYOof a patient's heart PH. Stent 10 preferably extends from the leftventricle LV of heart PH to a clogged coronary artery CA at a pointdownstream of a blockage BL to create a shunt 12 therethrough. Stent 10is preferably made of a biocompatible material such as stainless steelor nitinol, although other materials such as Ti, Ti alloys, Ni allows,Co alloys and biocompatible polymers may also be used. Stent 10preferably has a one way valve 14 to allow blood to flow from the leftventricle LV to the coronary artery CA. Although the stent 10 mayelastically deform under the contractive pressure of the heart muscleduring systole, the stent remains open to allow blood to pass from thepatient's left ventricle LV into the coronary artery CA. Duringdiastole, the blood pumped into coronary artery through shunt 12 isblocked by one-way valve 14 from returning to left ventricle LV. Furtherdetails are disclosed in U.S. Pat. No. 5,429,144, the entirety of whichis hereby incorporated by reference. Other types of stents may also beused in accordance with the preferred embodiments described herein.

[0062]FIG. 2 illustrates another application for which it is desirableto dispose a stent into the myocardium of a patient. In thisapplication, a stent 10 is provided partially through the myocardium MYOfrom the left ventricle LV. The stent 10 guides blood directly into themyocardium MYO from the left ventricle to replenish oxygen-deprivedheart muscle. Further details are disclosed in the above-referenced U.S.Pat. No. 5,429,144. Other applications providing a stent in themyocardium, extending either partially or entirely therethrough andaccessed from either the coronary artery or the left ventricle, are alsocontemplated by the present invention.

[0063] To achieve some or all of the objects of the present invention,in particular creating a myocardial passageway between the leftventricle LV and the coronary artery CA for disposition of a stenttherein, requires a delivery system capable of directing the necessarydevices to and into the myocardium. As described in further detailbelow, the suitable delivery system: (1) provides access to theinsertion site adjacent the myocardium; (2) creates an angled bend fortransverse insertion of devices into the myocardium; and (3) directsdevices into the myocardium for creation of the myocardial passageway.

[0064] I. Access to the Myocardium

[0065] The delivery system described herein preferably comprises one ormore catheters or guidewires inserted percutaneously into the body, suchas through the femoral artery and advanced in the patient's vasculaturethrough the aorta AO, shown in FIG. 1A. It should be appreciated thatthe percutaneous approach is not essential to achieve many of theobjects of the invention, and therefore, an open-chest or other approachmay also be used.

[0066] As shown in FIG. 3A, an exemplary delivery catheter or guidewire20 which has been advanced percutaneously through the femoral artery andthrough aorta AO is advanced through the blockage BL in the coronaryartery CA. The distal tip 22 of the catheter is delivered past theblockage so that it is positioned adjacent to a desired insertion pointinto the myocardium MYO. FIG. 3B shows an alternative access methodwherein the catheter 20 is delivered to a position adjacent themyocardium through the left ventricle LV.

[0067]FIGS. 4A and 4B depict an alternative access route used when ablockage in the coronary artery is too large for the catheter to bepassed therethrough. In this alternate embodiment, a delivery catheter20 enters the body through an access point preferably in the femoralvein (not shown). The catheter is advanced up the vein to the vena cavaVC and into the right atrium RA, as shown in FIG. 4A. Then, the catheter20 is directed into the coronary sinus CS, and then to the coronary veinCV which runs adjacent to the coronary artery CA.

[0068] As shown in FIG. 4B, after the distal tip 22 of catheter 20 ispast the blockage BL in the adjacent coronary vein, the deliverycatheter 20 is inserted through the vessel wall VW separating thecoronary vein CV from the coronary artery CA. Steering of catheter 20between coronary vein CV and coronary artery CA may be accomplishedusing the methods and apparatus for turning catheters discussed infurther detail below, or other suitable methods. As described in furtherdetail below, the delivery catheter is turned toward the myocardium MYOeither for insertion into the myocardium or for directing a guidewire topuncture therethrough. Access to the insertion point may also beaccomplished by steering the delivery catheter through the coronaryartery CA to a point proximal to the blockage, directing the catheterinto the coronary vein to bypass the blockage, and reinserting thecatheter from the coronary vein into the coronary artery past theblockage, as shown in FIG. 4B.

[0069] An alternative method of accessing the myocardium MYO when theblockage BL is too large to pass a catheter therethrough employscreating a channel around the blockage. As illustrated in FIG. 5, atunnel 24 is created from the coronary artery CA into the myocardium MYOat a point proximal to the blockage BL. The tunnel may be created usingradiation, lasers, or a surgical drill, or any other suitable methodsfor creating a tunnel. The tunnel 24 extends underneath the blockage BLand connects with the coronary artery CA at a point distal to theblockage BL. As shown in FIG. 6, a delivery catheter 20 is advancedthrough the coronary artery CA, into the tunnel 24, and back into thecoronary artery CA past the blockage BL. It will be appreciated thatother methods for diverting a delivery catheter around a blockage may beused, such as directing the catheter through a shunt into thepericardial space outside the coronary artery.

[0070] While the tunnel 24 shown in FIG. 6 is described as providingaccess to a myocardial insertion point for a coronary bypass, it shouldalso be appreciated that this tunneling technique may be useful forobliteration of the blockage BL. In particular, conventional methods forablating a blockage only permit access to the blockage from one side. Byemploying the tunneling method shown in FIG. 6. however, a blockage BLcan be treated not only from its proximal end, but also from its distalend simultaneously.

[0071] In an alternative embodiment, a tunnel is created through themyocardium MYO from a point proximal to a blockage in the coronaryartery into the left ventricle. As shown in FIG. 7, where a blockage BLsubstantially occludes a coronary artery CA, a first tunnel 26 is formedproximally of the blockage BL extending into the myocardium MYO beneaththe blockage BL. The tunnel 26 has a proximal end 28 which opens intothe coronary artery CA proximal to the blockage BL, and a distal end 30within the myocardium MYO beneath the blockage BL. A second tunnel 32extends from the distal end 30 of the first tunnel, with a first branch34 opening a channel to the coronary artery CA past the location of theblockage BL. A second branch 36 of the second tunnel 32 extends downwardfrom the distal end 30 and opens into the left ventricle LV. Asillustrated in FIG. 7, a substantially Y-shaped passageway is therebycreated through the myocardium MYO to bypass the blockage BL.

[0072] As shown in FIG. 8, after formation of the Y-shaped passageway inthe myocardium MYO, one or more stents 10 are provided in the secondtunnel 32 extending between the left ventricle LV and the coronaryartery CA. This stent 10 opens the myocardial passageway which providesthe bypass past blockage BL. Positioning of stent 10 in the tunnel 32 ispreferably accomplished by advancing a guidewire through the firsttunnel 26 and into each branch 34 and 36 of the second tunnel 32, andthen advancing the stent over the guidewire in the manner describedbelow. After placement of the stent, the tunnel 26 between the coronaryartery CA and stent 14 is preferably closed at least at distal end 30,and more preferably, also at proximal end 28. Closure of the tunnel maybe accomplished by inserting plugs or other blocking means 38, or bysealing the tunnel with sutures or similar methods. Other suitableclosure means include occlusion coils and balloons, adhesives such ascyanoacrylate, and plugs such as sold under the trade name GELFOAM.Alternatively, the tunnel may be closed due to the natural contractionof the openings 28 and 30 over time.

[0073] II. The Delivery Catheter

[0074] Once access to the desired insertion site is achieved, anappropriate delivery, system is brought to the site. The preferredembodiments described hereinbelow are directed to a delivery system forinserting stents and other medical devices into the myocardium at anangle relative to the axis of blood flow. It should be appreciated thatthe angle of insertion may be adjusted between 0 and 180 degreesdepending on the desired application. Furthermore, while the deliverysystems below describe insertion of devices into the myocardium, thesesystems also enable angled delivery of medical devices into and throughother body lumens and tissues.

[0075] A. Dual Balloon Delivery System

[0076] In one embodiment, the stent delivery system comprises a catheterWhich creates an angled bend for insertion of devices into themyocardium MYO. FIG. 9 illustrates a delivery catheter 40 which has beenadvanced into the coronary artery CA past the blockage BL. Catheter 40is an elongate tubular body 42 having a lumen 44 (not shown) extendingfrom a proximal end 46 (not shown) to a distal end 48. The catheter 40is preferably formed from a flexible biocompatible material such aspolymers, stainless steel or nitinol.

[0077] Mounted adjacent distal end 48 of catheter 40 are two steeringguides, Which are preferably expandable members such as inflatableballoon 50 and 52. As illustrated, a steering member, such as balloon52, is preferably located distally of an anchoring member, such asballoon 50, such that steering balloon 52 is disposed near or at thevery distal tip 48 of the catheter 40. Balloons 50 and 52 are eachpreferably mounted on opposite sides of the catheter tubular body 42,such that anchoring balloon 50 is mounted facing lower wall LW adjacentthe myocardium MYO, and steering balloon 52 is mounted facing upper wallUW opposite lower wall LW. Alternatively, the anchoring balloon 50 maybe mounted concentrically around the tubular body 42 so that inflationof the balloon expands against both the upper and lower walls, It willbe appreciated that other devices, such as filters, posts and otherexpandable members may be used for the anchoring and/or steeringmembers.

[0078] As shown in FIG. 9, as the catheter 40 is advanced into positionadjacent the myocardium MYO, the balloons 50 and 52 remain uninflated.As illustrated in FIG. 10, once the distal tip 48 of the catheter 40 ispositioned adjacent the desired insertion site into the myocardium MYO,the balloons 50 and 52 are inflated. Inflation causes the balloons 50and 52 to cooperate with the walls of the blood vessel to turn thedistal end of the catheter. More particularly, in an intermediate state,anchoring balloon 5G inflates against the lower wall LW of the coronaryartery CA, while steering balloon 40 presses against the upper wall UW.

[0079] As illustrated in FIG. 11, anchoring balloon 50 acts to securethe tubular body 42 within the coronary artery CA. Inflation of balloon50 also preferably causes the catheter 40 to displace in a directionopposite lower wall LW, thereby placing the catheter into a betterposition for transverse insertion of the distal end 48 into themyocardium MYO. Steering balloon 52 is further inflated, causing thedistal tip 48 of the tubular body 32 to turn downward towards lower wallLW and myocardium MYO due to the resistance provided by upper wall UWagainst the balloon. FIG. 11 also illustrates the effect that the dualballoon inflation may have on the upper and lower walls of the coronaryartery CA. When balloons 50 and 52 are fully inflated, forces created onthe lower wall LW and upper wall UW, respectively, may cause the wallsto shift at least slightly in the direction of balloon inflation. Inparticular, the lower wall LW may have a tendency to bend upwardsdistally of the balloon 50 toward the distal end 48 of delivery catheter40 to assist in angling of the catheter.

[0080] Due to the turning action of catheter 40 caused by inflation ofballoons 50 and 52, as well as the bending of lower wall LW towarddistal end 48, once inflation of the balloons 50 and 52 is complete, thedistal tip 48 of catheter 30 is positioned at a substantially transverseangle to the lower wall LV of the coronary artery CA and the myocardiumMYO. From this position, the catheter 40 may serve as a guide for thedelivery of devices used in creating a myocardial passageway. Forexample, as shown in FIG. 11 and described in further detail, below, apuncture wire or guidewire 100 is advanced through the lumen 44 oftubular body 42, and then ejected out the distal tip 48 of the catheter40 to puncture the lower wall LW into the myocardium

[0081] B. Pull Wire Actuator

[0082]FIG. 12 illustrates another embodiment for delivering devicestransversely into the myocardium MYO of a patient's heart. A catheter 54is shown extending through the coronary artery CA past a blockage BL.Catheter 54 comprises an elongate tubular body 56 with a lumen 58 (notshown) extending therethrough from a proximal end 60 (not shown) to adistal end 62. A tip-deflecting puncture wire or pull wire 64 extendsfrom the distal end 62 of the catheter 54. The wire 64 is actuated atthe proximal end (not shown) so that it deflects to form a near 90degree angle relative to the catheter 54. The distal tip 66 of wire 64is turned so that it is provided adjacent the myocardium MYO. This shapecan be locked and the wire 64 is pushed forward through the coronaryartery CA and into the wall of the myocardium MYO. As described infurther detail below, with the wire 64 in place medical devices aredelivered over the wire into the myocardium.

[0083] C. Side Port

[0084] In another embodiment, a delivery catheter is provided with aside port which allows a puncture wire to exit therethrough. As shown inFIGS. 13A and 14A, delivery catheter 70 comprises an elongate tubularbody 72 having a proximal end 76 (not shown) and a distal end 78 and alumen 74 (not shown) extending at least partially therethrough.Preferably, mounted on distal end 78 is an expandable or anchoringmember such as inflatable balloon 80, which is inflated to maintain theposition of the catheter 70 within the artery. The balloon 80 ispreferably a perfusion type balloon having a channel 86 to allow bloodflow through the artery during the procedure Alternatively, filters orother devices which allow blood flow through the artery while anchoringthe catheter 70 may also be utilized. Perfusion may also be providedthrough a lumen in the tubular body 72. A distal opening or side portexit 82 is provided through the wall of tubular body 72 near the distalend of the catheter extending. from lumen 74. The side port 82 may belocated either proximal to the balloon 80, as in FIG. 13A, or distal tothe balloon 80, as in FIG. 14A. Catheter 70 is delivered through thevasculature until the side port exit 82 is past the location of theblockage BL. Prior to balloon inflation, the catheter 70 is turned aboutits longitudinal axis so that the opening 82 faces the myocardium.

[0085]FIGS. 13B and 14B illustrate the pathway for a guidewire 100 topass through the lumen 74 of catheter 70. In FIG. 13B, guidewire 100extends through the lumen 74 toward the distal end 78 of the catheter.Proximal to balloon 80, the lumen 74 turns downward toward side portexit 82. Thus, before guidewire 100 reaches the proximal end of balloon80, the guidewire 100 is directed out of the side port 82 toward thelower wall LW of the coronary artery CA. A second lumen 84 is alsoprovided within catheter 70 to direct inflation fluid to balloon 80.

[0086]FIG. 14B shows substantially the same configuration except thatthe lumen 74 extends through the balloon 80 such that the side port exit82 is located distal to the balloon 80. Guidewire 100 therefore extendsthrough lumen 74 and out side port exit 82 toward the lower wall LW. Aswith FIG. 13B, a second lumen 84 is provided through tubular body 72 todirect inflation fluid into the balloon 80.

[0087] In another embodiment, as shown in FIG. 15A, the side port 82 islocated on an exterior surface of the balloon 80. After the catheter 70is delivered to a location past the blockage BL, balloon 80 is inflated.As shown. in the cross-sectional view of FIG. 15B, balloon 80 preferablycomprises a perfusion channel 86 extending from the proximal end to thedistal end of the balloon 80 to allow blood to flow through the vessel.A lumen 74 is provided through the catheter 70 which extends intoballoon 80 and turns downward into side port exit 82. The catheter 70also has a lumen 84 for inflation of balloon 80. Guidewire 100 isadvanced through lumen 74 and out side port exit 82 into the myocardiumMYO.

[0088]FIGS. 15C and 15D illustrate yet another embodiment of a deliverycatheter with a side-port exit. The catheter 70 comprises an elongatetubular body 72 having a lumen 74 extending from a proximal end 76 (notshown) to distal end 78. This lumen 74 is in fluid communication withballoon 80 to provide inflation of the balloon. When inflated, balloon80 has a perfusion lumen 86 which allows blood to perfuse therethrough.The balloon 80 also has a guide lumen 88 extending therethrough which,when inflated, extends from a proximal end of the balloon to the lowerwall LW. A guidewvire 100 may then be inserted through the guide lumen88 and out side port exit 82 into the myocardium MYO.

[0089] The delivery catheters described and shown in FIG. 15A-15D areuseful not only for disposing a stent into the myocardium but also forthe treatment of aneurysms. Aneurysms are typically treated byintroducing embolic elements to fill the aneurysm. When the aneurysmopens substantially into the blood vessel, it becomes difficult toretain the embolic elements within the aneurysm while the aneurysm isbeing filled. FIG. 16 illustrates a method for solving this problemusing the delivery catheter 70 described above with respect to FIGS. 15Cand 15D. In a blood vessel 90 with an aneurysm 92, a catheter 70carrying inflatable balloon 80 is advanced such that the balloon 80 isadjacent the aneurysm 92. The balloon 80 is inflated to substantiallyenclose the aneurysm 92. A wire 94 or other embolic element is advancedthrough the guide lumen 88 of balloon 80 and out side port 82. The wire94 fills up the aneurysm 92, and is maintained in the aneurysm due tothe fact that the balloon 80 encloses the aneurysm to prevent wire 94from extending into the vessel. It should be appreciated that the wire94 or other embolic element may also be delivered through a lumen 74, asshown with respect to the embodiment in FIG. 15B. After the aneurysm 92is filled with wire 94, the w%ire 94 is cut, the balloon 80 is deflated,and the catheter 70 is removed from the vessel.

[0090] III. Anchoring Guidewire

[0091] The embodiments described above are directed primarily toproviding a guidewire 100 into the patient's myocardium. As described infurther detail below, this guidewire is used for delivering medicaldevices into the myocardium. However, it should be appreciated that manyof the embodiments described above may also be used in conjunction withother methods for creating a passageway through the myocardium. Forinstance, a delivery catheter, such as described above, may be used fordelivering a surgical drill or other tissue penetrating device ejectedfrom the distal end thereof. This approach would be useful, forinstance, in creating a tunnel through the myocardium as describedabove. Alternatively, a Seldinger wire may be ejected from the distalend of the delivery catheter. Further details are described in theabove-referenced U.S. Pat. No. 5,429,144.

[0092] As shown in FIG. 17, a puncture device such as guidewire 100 isdirected into the myocardium 100 using any of the preferred methodsdescribed above. Guidewire 100 preferably has a proximal end 102 (notshown) which remains outside the patient's body, and a distal end 104which is inserted through a delivery catheter as described above. Wherethe delivery catheter is provided through the coronary artery, theguidewire is advanced in one embodiment until the distal end 104 of theguidewire enters the left ventricle. Alternatively, where it is desiredthat a stent or other device extend only partially into the myocardium,the guidewire 100 need not extend all the way through to the leftventricle. The distal tip 104 of the guidewire 100 is preferably made ofa radiopaque material that can be visualized by the physician by anavailable method, such as fluoroscopy.

[0093] The distal end of the guidewire 100 is preferably formed suchthat it is easily advanced but is difficult to pull back through thetissue. As shown in FIG. 17, one embodiment of the distal tip 104comprises one or more barbs 106 extending from the tip in a type of“multi-winged arrowhead” configuration. These barbs allow the guidewireto be advanced distally into the myocardium but require more force topull the guidewire 100 proximally out of the myocardium, thus creatingan effective anchor.

[0094]FIG. 18A shows another embodiment wherein a guidewire 100 carriesan expandable member such as balloon 10 on its distal end. Use of anexpandable member reduces damage to the myocardium during subsequentretraction of the wire 100. As illustrated in FIG. 18B, once the balloon110 reaches the left ventricle LV, the balloon 110 is inflated. Theballoon is then preferably pulled proximally back to the ventricle wallto anchor and secure the guidewire 100 in place.

[0095] Alternatively, FIGS. 19A-19C show an expandable guidewire 100extending through and actuated to anchor the guidewire within themyocardium MYO. In FIG. 19A, a guidewire 100 is shown advanced throughthe myocardium MYO. Guidewire 100 is provided with an expandable device112 on distal end 104 which may be actuated by an operator at theproximal end of the guidewire outside of the patient. Actuating of thedevice may be accomplished by using a shape memory material such asnitinol and heating the material above its transformation temperature.Alternatively, the guidewire may be mechanically actuated to assume thedesired shape. FIG. 19B shows the guidewire 100 partially actuated atits distal end 104 to expand the device 112 into an anchorable shape.FIG. 19C shows the expandable device 112 fully actuated to anchor theguidewire 100 against the ventricle wall. Other types of anchoring andexpandable members may also be used to secure the guidewire 100.

[0096] Once the guidewire 100 is anchored in place, the deliverycatheter may be removed without displacing the guidewvire insertedthrough the myocardium. Then, with the guidewire 100 anchored in place,catheters used in creating and stenting the passageway or other medicaldevices may be provided into the myocardium. Alternatively, the deliverycatheter may remain within the blood vessel and other catheters ormedical devices may be advanced over the guidewire and through thedelivery catheter. Furthermore, an expandable member such as a balloonmay be provided on the delivery catheter or on the guidewire 100 toanchor the catheter or guidewire to the wall of the blood vessel toprovide for more secure deployment of medical devices into themyocardium.

[0097] IV. Delivery Over the Guidewire

[0098] The anchoring of the guidewire 100 within the myocardium MYOallows for the delivery of devices into the myocardium for creation of amyocardial passageway. In particular, the anchoring of the guidewire 100facilitates advancement of over-the-wire catheters such as introducercatheters into the myocardium by employing a push-pull mechanism. Whenit is desired to push a catheter over the guidewire 100, the guidewire100 may be pulled proximally by an operator from outside of the body.The anchoring member at the distal end of the guidewire, whether aballoon, barb. or other member, prevents the guidewire 100 from exitingthe myocardium MYO. Meanwhile, a delivery catheter or otherover-the-wire device may be pushed into the myocardium MYO, assisted bythe pulling force of the anchoring member toward the catheter. Theanchoring member also assists in placement of an over-the-wire catheterin the myocardium by preventing the catheter from extending beyond thelocation of the anchoring member.

[0099] As illustrated in FIG. 20, to create a myocardial passageway, acatheter 120 having a dilation balloon 122 is advanced over guidewire100, into the myocardium MYO, as shown in FIG. 21. The anchored balloon110 acts as a barrier to advancement of balloon 122, which issubsequently inflated within myocardium MYO to expand a myocardialpassageway. The balloon 122 is then deflated and the catheter 120removed. The process may be repeated with successively larger dilationballoons to form a passageway of desired size.

[0100] After inflation of the largest desired dilation balloon, thecatheter 120 is withdrawn and a stent introducer catheter 130 isadvanced over wire 100, as shown in FIG. 22. The catheter 130 has aninflatable balloon 132 mounted on its distal end for deploying a stent134 carried by balloon 132. Upon the positioning of balloon 132 insidethe myocardium MYO, balloon 132 is inflated, as shown in FIG. 23. toassist in an initial expansion of stent 134 in opposition to thecompressive forces of the heart muscle. Upon the desired disposition ofstent 134, balloon 132 is deflated and catheter 130 and wire 100 arewithdrawn, leaving stent 134 in place to provide a coronary bypassbetween ventricle LV and artery CA.

[0101] V. Drug Delivery

[0102] The guidewire such as described above delivered into themyocardium MYO may also be used for delivering drugs into themyocardium. As shown in FIG. 24, a guidewire 140 is advanced partiallyinto the myocardium using any of the methods described above. Theguidewire 140 comprises a tubular body 142 having a lumen-148 (notshown) extending from a proximal end 144 (not shown) to a distal end146. The guidewire may be angled using the turning methods describedabove to provide the distal end of the guidewire at a desired positionwithin the myocardium for drug delivery. Drug delivery fluids 150 areejected from the distal and 146 into 5 the myocardium. Although theguidewire 140 shown in FIG. 24 is not anchored to the myocardium MYO,anchoring means as described above may be provided. Furthermore, theguidewire 140 may contain a plurality of ports 152 along the tubularbody 142 near the distal end 146.

[0103] The embodiments illustrated and described above are providedmerely as examples of certain preferred embodiments of the presentinvention. Other changes and modifications can be made from theembodiments presented herein by those skilled in the art withoutdeparture from the spirit and scope of the invention, as defined by theappended claims.

What is claimed is:
 1. A method for delivering a medical device into themyocardium of a patient, comprising: delivering a guidewire into thepatient, the guidewire once delivered having a proximal end extendingout of the patient and a distal end positioned adjacent the myocardium;inserting the distal end of the guidewire into the myocardium; anchoringthe guidewire to the myocardium; and advancing an introducer cathetercarrying the medical device over the guidewire to deliver the deviceinto the myocardium.
 2. The method of claim 1, wherein the guidewire isdelivered percutaneously into the patient.
 3. The method of claim 2,wherein the distal end of the guidewire is advanced through a blockagein a coronary artery.
 4. The method of claim 2, wherein the distal endof the guidewire is advanced through a coronary vein.
 5. The method ofclaim 2, wherein the distal end of the guidewire is advanced into theleft ventricle.
 6. The method of claim 1, further comprising advancing adelivery catheter into the patient prior to delivering the guidewire,the delivery catheter comprising a tubular body having a proximal endand a distal end and a lumen extending at least partially therethrough,until the distal end of the delivery catheter is positioned adjacent themyocardium.
 7. The method of claim 6, further comprising turning thedistal end of the guidewire toward the myocardium prior to inserting thedistal end of the guidewire, by: actuating an anchoring member mountedon the distal end of the delivery catheter to secure the deliverycatheter within the patient; and actuating a steering member mounted onthe distal end of the tubular body at a position distal to that of theanchoring member to turn the distal end of the delivery catheter towardthe myocardium; and advancing the guidewire through the lumen in thedelivery catheter and out the distal end of the delivery catheter. 8.The method of claim 1, wherein the guidewire is a tip-deflecting wire,and further comprising turning the distal end of the guidewire towardthe myocardium prior to inserting the distal end of the guidewire byactuating the tip-deflecting wire.
 9. The method of claim 1, furthercomprising: providing a passageway adjacent the myocardium having aproximal opening for receiving the distal end of the guidewire and aside port exit facing the myocardium; wherein delivering the guidewirecomprises advancing the distal end of the guidewire through thepassageway toward the myocardium.
 10. The method of claim 9, wherein thepassageway is provided through a lumen in a delivery catheter.
 11. Themethod of claim 9, wherein the passageway is provided through ananchoring member mounted to a distal end of a delivery catheter.
 12. Themethod of claim 1, wherein anchoring the guidewire to the myocardiumcomprises providing at least one barb attached to the distal end of theguidewire, the barb having a shape that facilitates advancement of theguidewire distally through the myocardium but prevents retraction of theguidewire proximally.
 13. The method of claim 1, wherein inserting thedistal end of the guidewire into the myocardium comprises advancing theguidewire from a coronary blood vessel until the distal end extends intothe left ventricle.
 14. The method of claim 1, wherein anchoring theguidewire further comprises expanding an anchoring member mounted on thedistal end of the guidewire within the left ventricle.
 15. The method ofclaim 14, wherein the anchoring member is an inflatable balloon.
 16. Themethod, of claim 1, wherein advancing the introducer catheter carrying amedical device further comprises: pulling proximally on the guidewireanchored to the myocardium; and pushing the introducer catheter over theguidewire into the myocardium.
 17. A method for delivering a stent intothe myocardium to bypass a blockage formed in a coronary artery,comprising: creating a channel from a position proximal to the blockagein the coronary artery to a position distal to the blockage in thecoronary artery; advancing a guidewire through the channel until adistal end of the guidewire is adjacent the myocardium; inserting theguidewire into the myocardium; and advancing a stent over the guidewireinto the myocardium.
 18. The method of claim 17, wherein the channel isa tunnel formed through the myocardium.
 19. A method for creating abypass through the myocardium of a patient to bypass a blockage formedin a coronary artery, comprising: creating a first tunnel through themyocardium having a proximal end and a distal end, the proximal endopening into the coronary artery proximal to the blockage, and thedistal end positioned within the myocardium; creating a second tunnelthrough the myocardium, the second tunnel having a first branchextending from the distal end of the first tunnel and opening into thecoronary artery at a position distal to the blockage, and a secondbranch extending from the distal end of the first channel and openinginto the left ventricle; and disposing a stent in the second tunnel toprovide a myocardial passageway therethrough.
 20. The method of claim19, further comprising closing off the first tunnel at the distal endthereof.
 21. The method of claim 19, further comprising closing off thefirst tunnel at the proximal end thereof.
 22. A delivery catheter,comprising: an elongate tubular body having a proximal end and a distalend and a lumen extending therethrough; a first steering member mountedon the distal end of the tubular body; and a second steering membermounted on the distal end of the tubular body at a position distal tothat of the anchoring member.
 23. The catheter of claim 22, wherein thefirst steering member is an expandable anchoring member which, whenactuated, is sized to press against a wall of the body lumen to securethe catheter within the lumen.
 24. The catheter of claim 23, wherein thesecond steering member is an expandable member which, when actuated,cooperates with a wall of the body lumen to turn the distal end of thecatheter.
 25. The catheter of claim 22, wherein the anchoring member andsteering member are inflatable balloons.
 26. The catheter of claim 22,wherein the anchoring member is mounted to one side of the tubular bodyand the steering member is mounted to an opposite side of the tubularbody.
 27. A method for turning a distal end of a catheter within a bodylumen. the catheter comprising an elongate tubular body having aproximal end and a distal end, the method comprising: actuating ananchoring member mounted on the distal end of the tubular body to securethe catheter against the body lumen; and actuating a steering membermounted on the distal end of the tubular body at a position distal tothat of the anchoring member, wherein the steering member when actuatedcooperates with the body lumen to turn the distal end of the catheter.28. The method of claim 27, wherein the anchoring member and thesteering member are inflatable balloons.
 29. A method for delivering amedical device to a delivery site within a patient comprising: providinga delivery catheter having a proximal end and a distal end and a lumenextending therethrough into a body lumen of the patient; securing thedelivery catheter within the body lumen; turning the distal end of thecatheter by actuating a steering member mounted on the distal end of thecatheter which pushes off against a wall of the body lumen; andadvancing the medical device through the lumen of the delivery catheterand out the distal end.
 30. The method of claim 29, wherein the steeringmember when actuated pushes off a wall of the body lumen to turn thedistal end of the catheter.
 31. The method of claim 29, wherein securingthe delivery catheter comprises actuating an anchoring member mounted onthe distal end of the catheter against the wall of the body lumen. 32.The method of claim 31, wherein actuating the anchoring member comprisesinflating a balloon against the wall of the body lumen.
 33. The methodof claim 29, wherein actuating the steering member comprises inflating aballoon against the wall of the body lumen.
 34. A method for deliveringa stent into the myocardium of a patient, comprising: advancing adelivery catheter into the vasculature of the patient, the deliverycatheter having a proximal end and a distal end and a lumen extendingtherethrough, until the distal end is adjacent the myocardium; actuatinga pull wire extending from the distal end of the delivery catheter toturn the pull wire toward the myocardium; advancing the pull wire fromthe distal end of the delivery catheter into the myocardium; anddelivering the stent over the pull wire into the myocardium.
 35. Amethod for delivering a stent into the myocardium of a patient,comprising: advancing a delivery catheter into the vasculature of thepatient, the catheter having a proximal end and a distal end and a lumenextending from the proximal end to a side port near the distal end,until the side port faces the myocardium; inserting a guidewire having aproximal end and a distal end into the lumen; advancing the distal endof the guidewire through the lumen and out the side port; puncturing theguidewire into the myocardium; and delivering the stent over theguidewire into the myocardium.
 36. The method of claim 35, furthercomprising anchoring the delivery catheter within the vasculature. 37.The method of claim 35, wherein anchoring of the delivers cathetercomprises expanding an anchoring member mounted to the distal end of thedeliver, catheter.
 38. The method of claim 37, wherein the anchoringmember is an inflatable balloon.
 39. The method of claim 37, furthercomprising perfusing blood through at least on channel in the anchoringmember.
 40. A method for delivering a stent into the myocardium of apatient, comprising: advancing a delivery catheter into the vasculatureof a patient, the catheter having a proximal end and a distal end, untilthe distal end is adjacent the myocardium; expanding an anchoring membermounted on the distal end of the catheter to secure the deliverycatheter within the vasculature; inserting a guidewire having a proximalend and a distal end through a lumen in the expanded anchoring member,the lumen extending from a proximal end of the anchoring member to aside port facing the myocardium, so that the distal end of the guidewireexits through the side port; puncturing the guidewire into themyocardium; and advancing the stent over the guidewire into themyocardium.
 41. The method of claim 40, wherein expanding the anchoringmember comprises inflating a balloon.
 42. The method of claim 40,further comprising perfusing blood through at least one channel in theexpanded anchoring member.
 43. A delivery catheter, comprising: anelongate body having a proximal end and a distal end; an expandablemember mounted on the distal end of the tubular body. the expandablemember having a proximal end and a distal end and an exterior surface;and to a guide lumen extending from the proximal end of the balloon to aside port on the exterior surface of the expandable member for directinga medical device therethrough.
 44. The delivery catheter of claim 43,wherein the guide lumen extends through the elongate body from the sideport to the proximal end of the elongate body.
 45. The delivery catheterof claim 43, wherein the guide lumen is separate from the elongate body.46. The delivery catheter of claim 43, wherein the guide lumen curses upto about 90 degrees.
 47. The delivery catheter of claim 43, wherein theexpandable member is an inflatable balloon.
 48. The delivery catheter ofclaim 43, further comprising a perfusion channel to allow blood to flowtherethrough.
 49. The delivery catheter of claim 48, wherein theperfusion channel extends through the expandable member.
 50. A methodfor treating an aneurysm, comprising: advancing a catheter having aproximal end and a distal end to the site of the aneurysm; actuating anexpandable member mounted on the distal end of the catheter tosubstantially enclose the aneurysm; and inserting an embolic elementthrough a lumen in the expandable member into the aneurysm.
 51. Themethod of claim 50, wherein actuating the expandable member comprisesinflating a balloon.
 52. The method of claim 50, further comprisingperfusing blood through at least one channel in the expandable member.53. The method of claim 50, wherein the embolic element is a wire.
 54. Amethod for delivering a medical device into a body tissue of a patientcomprising: inserting a guidewire having a proximal end and a distal endinto the myocardium from a coronary blood vessel; anchoring theguidewire to the body tissue; pushing the medical device over theguidewire into the body tissue; and pulling on the proximal end of theguidewire while advancing the medical device through the body tissue.55. The method of claim 54, wherein anchoring the guidewire comprisesactuating an expandable member.
 56. The method of claim 55, wherein theexpandable member is an inflatable balloon.
 57. The method of claim 54,further comprising providing at least one barb on the distal end of theguidewire to anchor the guidewire to the myocardium.
 58. A deliverysystem for directing a medical treatment at least partially into themyocardium, comprising: a guidewire having a proximal end and a distalend; means for turning the distal end of the guidewire toward themyocardium; means for anchoring the guidewire to the myocardium; and acatheter carrying the medical treatment having a lumen extendingtherethrough for receiving the guidewire and advancing the catheter intothe myocardium.
 59. A method for delivering a stent into the myocardiumof a patient to bypass a blockage formed in a coronary artery,comprising: advancing a catheter having a proximal end and a distal endand a lumen extending at least partially therethrough from the proximalend to a distal opening through the coronary artery of the patient untilthe distal opening is past the blockage; turning the catheter so thatthe distal opening faces the myocardium; extending a wire having aproximal end and a distal end through the distal opening such that thedistal end punctures into the myocardium; anchoring the distal end ofthe wire to the myocardium; delivering a dilation catheter over thewire, the catheter carrying a dilation balloon on a distal end thereof,until the balloon is within the myocardium; inflating the dilationballoon to create an opening in the myocardium; deflating the dilationballoon and removing the dilation catheter from the wire; delivering astent introducer catheter over the wire, the stent introducer cathetercarrying a stent on a distal end thereof, until the stent is locatedwithin the opening in the myocardium, and deploying the stent within theopening in the myocardium.
 60. A method for delivering medical treatmentinto the myocardium of a patient, comprising: delivering a tubular wirehaving a lumen extending therethrough into the patient, the wire oncedelivered having a proximal end extending out of the patient and adistal end positioned adjacent the myocardium; providing a means forturning the distal end of the wire towards the myocardium; inserting thedistal end of the wire into the myocardium; and delivering the medicaltreatment through the lumen in the wire into the myocardium.
 61. Themethod of claim 60, wherein delivering medical treatment through thelumen comprises providing drug fluid into the lumen at the proximal end.62. The method of claim 60, wherein the distal end of the wire furthercomprises at least one exit port.
 63. The method of claim 60, whereinthe means for turning the distal end comprises delivering the wirethrough a delivery catheter.
 64. The method of claim 63, wherein themeans for turning the distal end further comprises: actuating ananchoring member mounted on a distal end of the delivery catheter tosecure the delivery catheter within the patient; and actuating asteering member mounted on the distal end of the tubular body at aposition distal to that of the anchoring member to turn the distal endof the delivery catheter toward the myocardium.
 65. The method of claim60, wherein the tubular wire is a pull wire, and the means for turningthe distal end comprises actuating the pull wire.
 66. The method ofclaim 60, wherein the means for turning the distal end comprises:providing a curved passageway adjacent the myocardium having a proximalopening for receiving the distal end of the tubular wire and a side portexit facing the myocardium; and delivering the tubular wire through thecurved passageway.
 67. The method of claim 66, wherein the passageway isprovided through a lumen in a delivery catheter.
 68. The method of claim66, wherein the passageway is provided through an anchoring membermounted to a distal end of a delivery catheter.